NCT02723032

Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.

Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.

Detailed description

Objectives: 1. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation. 2. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).

Conditions

• Pulse Oximeter Validation
• Long Term Oxygen Therapy
• Hypoxemia

Interventions

Type	Name	Description
DEVICE	OxyFrame	Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2016-03-30
• Last updated: 2016-10-27

Locations

1 site across 1 country: Switzerland